Ostomy skin barrier device

Abstract

The present invention provides a stoma skin barrier device comprising: a front side and a back side wherein at least a portion of the front side comprises a medical adhesive wherein the medical adhesive comprises at least one pre-gelatinized starch or pre-gelatinized modified starch; and an opening on the skin barrier device, the opening being capable of at least partially receiving a stoma in use.

Description

Technical Field

[0001] This invention relates to an ostomy skin barrier device comprising a medical adhesive, and the medical adhesive. Background Technology

[0002] Medical adhesives often contain gelatin, especially animal-derived gelatin, which can have negative effects such as increasing the risk of viral infections. The use of gelatin-containing medical adhesives may also be restricted; for example, they cannot be used on broken skin unless they meet the requirements for Class II or Class III medical devices. Patients who require long-term use of medical adhesives, such as ostomy patients, may prefer alternatives that do not contain animal-derived ingredients without compromising the performance of the medical adhesive.

[0003] Therefore, it would be advantageous to provide a gelatin-free medical adhesive for long-term use (e.g., for ostomy bags). It would also be advantageous to provide an ostomy skin barrier device comprising a gelatin-free medical adhesive for long-term use.

[0004] A skin barrier device comprising a medical adhesive is provided, wherein the skin barrier device has good wet integrity, is not corroded by water, and is enzyme-resistant, thus also not corroded by enzymes, which is advantageous. A skin barrier device for an ostomy bag is provided, comprising a medical adhesive, wherein the skin barrier device has good wet integrity, is not corroded by water, and is enzyme-resistant, thereby protecting the patient's skin from irritation, which is advantageous. A skin barrier device for an ileostomy bag is provided, comprising a medical adhesive, wherein the skin barrier device has good wet integrity, is not corroded by water, and is enzyme-resistant, thereby protecting the patient's skin from irritation by enzyme-containing exudates, which is advantageous.

[0005] The embodiments of the present invention are intended to overcome one or more problems of the prior art, whether or not such problems have been explicitly disclosed herein. Summary of the Invention

[0006] According to a first aspect of the invention, a stoma skin barrier device is provided, comprising: a front side and a back side, wherein at least a portion of the front side comprises a medical adhesive, wherein the medical adhesive comprises at least one pre-gelatinized starch or pre-gelatinized modified starch; and an opening on the skin barrier device, the opening being capable of at least partially accommodating the stoma during use.

[0007] Pregelatinization refers to a pre-cooking step in which starch or modified starch is heated with water to break the intermolecular bonds in the starch molecules, followed by drying. The advantage of pregelatinized starch or pregelatinized modified starch is that it improves the interaction between the starch or modified starch and other materials. Furthermore, pregelatinized starch or pregelatinized modified starch can improve wet integrity due to reduced loss of modified starch from the binder in the presence of water, which is another advantage. Pregelatinized starch or pregelatinized modified starch can also be advantageous because medical adhesives containing pregelatinized starch can absorb moisture at body temperature, thus maintaining the integrity of the medical adhesive when exposed to water.

[0008] Pregelatinized starch or pregelatinized modified starch may contain no more than 5% by weight of amylose. Pregelatinized starch or pregelatinized modified starch may contain no more than 4%, 3%, 2%, 1%, 0.8%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, or 0.1% by weight of amylose. Pregelatinized starch or pregelatinized modified starch may be amylose-free or substantially amylose-free. Pregelatinized starch or pregelatinized modified starch that is amylose-free or substantially amylose-free may contain only amylopectin polymer units (amylose) and not amylose polymer units (amylose). Pregelatinized starch or pregelatinized modified starch containing low amounts of amylose or no amylose may be advantageous because it can yield binders with improved wet integrity properties. Pregelatinized starch or pregelatinized modified starch containing low amounts of amylose can also have favorable wet integrity properties due to the high water solubility caused by the linear structure and low molecular weight of amylose, which reduces wet integrity.

[0009] Pregelatinized starch or pregelatinized modified starch may contain at least 95% by weight amylopectin. Pregelatinized starch or pregelatinized modified starch may contain at least 96%, 97%, 98%, or at least 99% by weight amylopectin. Pregelatinized starch or pregelatinized modified starch may contain 100% by weight amylopectin. Pregelatinized starch or pregelatinized modified starch containing a high amount of amylopectin has advantages because it can be used to prepare adhesives with improved wet integrity properties. The excellent wet integrity properties of pregelatinized starch or pregelatinized modified starch containing a high content of amylopectin are due to the branched structure and high molecular weight of amylopectin, which improves its stability when exposed to water, thereby improving the wet integrity of medical adhesives.

[0010] In some embodiments, the medical adhesive contains less than 5% by weight of gelatin. The medical adhesive may contain less than 4%, 3%, 2%, or less than 1% by weight of gelatin. In a preferred embodiment, the medical adhesive is substantially gelatin-free. The advantage of this embodiment is that the medical adhesive has high absorbency and good wettability, enabling it to absorb water or moisture from the skin without losing its physical form or detaching from the skin during use, thus ensuring that the stoma skin barrier device adheres firmly to the patient during use. Another advantage of this embodiment is its resistance to enzymes in stoma effluent. The advantage of gelatin-free adhesives is that they can be used on broken skin and help stoma devices using this medical adhesive meet the regulatory requirements of certain countries. The advantage of gelatin-free adhesives is also that they do not contain animal ingredients, thus eliminating the risk of viral infection that may originate from gelatin.

[0011] The medical adhesive may contain at least one pregelatinized modified starch. The pregelatinized modified starch may contain no more than 5% by weight of amylose.

[0012] The medical adhesive may contain at least one pregelatinized starch. The medical adhesive may contain at least one pregelatinized starch or pregelatinized modified starch, wherein the pregelatinized starch or pregelatinized modified starch contains no more than 20% by weight of amylose. The medical adhesive may also contain at least one pregelatinized starch or pregelatinized modified starch, wherein the pregelatinized starch or pregelatinized modified starch contains no more than 15% by weight, 10% by weight, or no more than 5% by weight of amylose.

[0013] In some embodiments, the crystallinity of the pregelatinized starch or pregelatinized modified starch does not exceed 5%. In some embodiments, the crystallinity of the pregelatinized starch or pregelatinized modified starch does not exceed 4%, 3%, 2%, 1%, or 0.5%. In some embodiments, the crystallinity of the pregelatinized starch or pregelatinized modified starch is substantially 0%. Reduced crystallinity can be achieved through a pregelatinization step of the pregelatinized starch or pregelatinized modified starch. Low or substantially non-crystallized pregelatinized starch or pregelatinized modified starch can be advantageous because it allows the pregelatinized starch or pregelatinized modified starch to absorb moisture at body temperature, thereby maintaining the integrity of the medical adhesive when exposed to water.

[0014] Pregelatinized starch or pregelatinized modified starch can be cross-linked. Pregelatinized starch or pregelatinized modified starch can be cross-linked with organic molecules. Pregelatinized starch or pregelatinized modified starch can be cross-linked with organic molecules containing at least three carbon atoms. Pregelatinized starch or pregelatinized modified starch can be cross-linked with dialdehydes or dicarboxylic acids containing at least three carbon atoms. Pregelatinized starch or pregelatinized modified starch can be cross-linked with adipate esters. In some embodiments, pregelatinized starch or pregelatinized modified starch is cross-linked with phosphorus compounds. Pregelatinized starch or pregelatinized modified starch can be cross-linked with phosphorus oxychloride. In some embodiments, pregelatinized starch or pregelatinized modified starch is not cross-linked. In one embodiment, pregelatinized starch or pregelatinized modified starch is not cross-linked with glyoxal.

[0015] Pregelatinized starch or pregelatinized modified starch can be derived from potatoes, corn, wheat or cassava.

[0016] Modified starch or pregelatinized modified starch may be selected from the following group: hydrochloric acid baked starch, alkali modified starch, bleached starch, oxidized starch, enzyme-treated starch, distarch phosphate, hydroxypropylated starch, starch ether, hydroxyethyl starch, cationic starch and carboxymethylated starch, or any combination thereof.

[0017] In a preferred embodiment, the pregelatinized modified starch is pregelatinized esterified starch. The pregelatinized modified starch can be pregelatinized oxidized starch. The pregelatinized modified starch can be pregelatinized distarch. The pregelatinized modified starch can be pregelatinized distarch phosphate. The pregelatinized modified starch can be pregelatinized acetylated distarch phosphate. The pregelatinized modified starch can be pregelatinized hydroxypropylated distarch phosphate. The pregelatinized modified starch can be pregelatinized distarch adipate. The pregelatinized modified starch can be pregelatinized acetylated distarch adipate. The structural formula of pregelatinized acetylated distarch adipate is as follows:

[0018] Pregelatinized acetylated distarch adipate can be derived from waxy corn. The crystallinity of pregelatinized acetylated distarch adipate does not exceed 5%, preferably about 0%. Pregelatinized acetylated distarch adipate is substantially free of amylose. Medical adhesives containing pregelatinized acetylated distarch adipate are advantageous because they offer improved wet integrity and improved enzyme resistance compared to gelatin-containing medical adhesives. Gelatin-free medical adhesives containing pregelatinized acetylated distarch adipate are advantageous because they offer comparable wet integrity and improved enzyme resistance compared to gelatin-containing medical adhesives.

[0019] In other embodiments, the pregelatinized hydroxypropyl distarch phosphate contains no more than 5% by weight of amylose, or is substantially free of amylose. Medical adhesives containing pregelatinized hydroxypropyl distarch phosphate are advantageous because they offer improved wet integrity and improved enzyme resistance compared to gelatin-containing medical adhesives. Gelatin-free medical adhesives containing pregelatinized hydroxypropyl distarch phosphate are advantageous because they offer comparable wet integrity and improved enzyme resistance compared to gelatin-containing medical adhesives.

[0020] In other preferred embodiments, the pregelatinized starch is pregelatinized potato starch. The pregelatinized potato starch contains no more than 25% amylose. Alternatively, the pregelatinized potato starch may contain no more than 20%, 15%, 10%, or no more than 5% amylose.

[0021] The amount of pregelatinized starch or pregelatinized modified starch may be from 10% to 40% by weight of the total weight of the medical adhesive. Alternatively, the amount of pregelatinized starch or pregelatinized modified starch may be from 10% to 35% by weight, 10% to 30% by weight, 15% to 40% by weight, 15% to 35% by weight, 15% to 30% by weight, 20% to 40% by weight, 20% to 35% by weight, or 20% to 30% by weight.

[0022] Medical adhesives may contain pectin and / or pectin derivatives. Pectin may be high-methoxyl pectin (at least 50% esterified). Pectin may be 50% to 80%, 50% to 70%, or 55% to 65% esterified. Pectin may be low-methoxyl pectin (less than 50% esterified). Pectin derivatives may be pectin modified by one of the following methods: alkylation, amidation, quaternization, thiolation, sulfation, oxidation, chain elongation, and depolymerization, or any combination thereof.

[0023] The amount of pectin or pectin derivatives may be from 10% to 30% by weight of the total weight of the medical adhesive. Alternatively, the amount of pectin or pectin derivatives may be from 12% to 28% by weight, 12% to 26% by weight, 12% to 25% by weight, or 13% to 25% by weight of the total weight of the medical adhesive. Or, the amount of pectin or pectin derivatives may be from 14% to 26% by weight, 15% to 25% by weight, 16% to 25% by weight, 18% to 25% by weight, 20% to 25% by weight, 18% to 23% by weight, 18% to 22% by weight, or 19% to 21% by weight of the total weight of the medical adhesive. In one embodiment, the amount of pectin or pectin derivatives may be from 18% to 20% by weight of the total weight of the medical adhesive. In other embodiments, the amount of pectin or pectin derivative may be 12 to 15% of the total weight of the medical adhesive.

[0024] The medical adhesive may contain polyisobutylene. The medical adhesive may contain at least one polyisobutylene compound. The medical adhesive may contain two polyisobutylene compounds. The average molecular weight of the polyisobutylene may be 50,000 gmol. - ¹Up to 110,000 gmol - ¹. The average molecular weight of this polyisobutylene can be 500,000 gmol. - ¹Up to 1,200,000 gmol - ¹.

[0025] The amount of polyisobutylene can be from 5% to 50% by weight of the total weight of the medical adhesive. In some embodiments, the amount of polyisobutylene is from 5% to 45% by weight, 5% to 40% by weight, or 5% to 35% by weight of the total weight of the medical adhesive. In one embodiment, the amount of polyisobutylene is from 30% to 48% by weight, 34% to 46% by weight, 35% to 45% by weight, 36% to 45% by weight, 38% to 45% by weight, 30% to 45% by weight, 38% to 43% by weight, 38% to 42% by weight, or 39% to 41% by weight of the total weight of the medical adhesive. In some embodiments, the amount of polyisobutylene is about 40% by weight of the total weight of the medical adhesive. In other embodiments, the amount of polyisobutylene is 5% to 30% by weight, 5% to 25% by weight, 5% to 20% by weight, 5% to 15% by weight, or 5% to 10% by weight of the total weight of the medical adhesive. In some embodiments, the amount of polyisobutylene is about 8% by weight of the total weight of the medical adhesive.

[0026] Medical adhesives may contain cellulose or cellulose derivatives. Cellulose derivatives may be modified cellulose. Cellulose derivatives may be methylcellulose. Cellulose derivatives may be hydroxypropylcellulose. In a preferred embodiment, the cellulose derivative is carboxymethyl cellulose.

[0027] The amount of cellulose or cellulose derivative may be from 10% to 30% by weight of the total weight of the medical adhesive. The amount of cellulose or cellulose derivative may be from 12% to 28% by weight, 14% to 26% by weight, 14% to 25% by weight, 14% to 24% by weight, 14% to 22% by weight, 15% to 25% by weight, 16% to 25% by weight, 18% to 25% by weight, 20% to 25% by weight, 18% to 23% by weight, 18% to 22% by weight, or 19% to 21% by weight of the total weight of the medical adhesive. In some embodiments, the amount of cellulose or cellulose derivative is about 20% by weight of the total weight of the medical adhesive. In other embodiments, the amount of cellulose or cellulose derivative is about 15% by weight of the total weight of the medical adhesive.

[0028] The medical adhesive may contain at least one additional component selected from the following: acrylate or acrylic resin, epoxy resin, silicone, polyurethane, natural rubber, styrene-isoprene-styrene copolymer (SIS or SIS / SI), butyl rubber, hydrocolloid, adhesive, tackifier, mineral oil, antioxidant and hydrogel or any combination thereof.

[0029] In some embodiments, the medical adhesive comprises butyl rubber. The butyl rubber may comprise at least 95 wt%, 96 wt%, 97 wt%, or at least 98 wt% polyisobutylene. The medical adhesive may comprise from 5 wt% to 30 wt% butyl rubber. The medical adhesive may comprise from 5 wt% to 25 wt%, 5 wt% to 20 wt%, or 10 wt% to 20 wt% butyl rubber.

[0030] The medical adhesive may contain 3% to 15% by weight of a styrene-isoprene-styrene copolymer. The medical adhesive may contain 5% to 15% by weight of a styrene-isoprene-styrene copolymer.

[0031] The medical adhesive may contain 5% to 20% by weight of a tackifier. The medical adhesive may contain 10% to 20% by weight or 5% to 15% by weight of a tackifier.

[0032] The medical adhesive may contain 5% to 20% by weight of mineral oil. Alternatively, the medical adhesive may contain 5% to 15% by weight or 10% to 20% by weight of mineral oil.

[0033] The medical adhesive may contain: 10 to 40% by weight of pregelatinized starch or pregelatinized modified starch; 10 to 30% by weight of pectin or pectin derivatives; 5 to 50% by weight of polyisobutylene; and 10 to 30% by weight of cellulose or cellulose derivatives.

[0034] The medical adhesive may contain: 10 to 25% by weight of pregelatinized starch or pregelatinized modified starch; 10 to 20% by weight of pectin or pectin derivatives; 5 to 50% by weight of polyisobutylene; and 10 to 30% by weight of cellulose or cellulose derivatives.

[0035] The medical adhesive may contain: 10 to 40% by weight of pregelatinized starch or pregelatinized modified starch; 10 to 30% by weight of pectin or pectin derivatives; 30 to 50% by weight of polyisobutylene; and 10 to 30% by weight of cellulose or cellulose derivatives.

[0036] The medical adhesive may contain: 15 to 35% by weight of pregelatinized starch or pregelatinized modified starch; 10 to 30% by weight of pectin or pectin derivatives; 30 to 50% by weight of polyisobutylene; and 10 to 30% by weight of cellulose or cellulose derivatives.

[0037] The medical adhesive may contain: 10 to 40% by weight of pregelatinized starch or pregelatinized modified starch; 15 to 25% by weight of pectin or pectin derivatives; 30 to 50% by weight of polyisobutylene; and 10 to 30% by weight of cellulose or cellulose derivatives.

[0038] The medical adhesive may contain: 10 to 40% by weight of pregelatinized starch or pregelatinized modified starch; 10 to 30% by weight of pectin or pectin derivatives; 35 to 45% by weight of polyisobutylene; and 10 to 30% by weight of cellulose or cellulose derivatives.

[0039] The medical adhesive may contain: 10 to 40% by weight of pregelatinized starch or pregelatinized modified starch; 10 to 30% by weight of pectin or pectin derivatives; 30 to 50% by weight of polyisobutylene; and 15 to 25% by weight of cellulose or cellulose derivatives.

[0040] The medical adhesive may contain: 15 to 35% by weight of pregelatinized starch or pregelatinized modified starch; 15 to 25% by weight of pectin or pectin derivatives; 35 to 45% by weight of polyisobutylene; and 15 to 25% by weight of cellulose or cellulose derivatives.

[0041] The medical adhesive may contain: about 20% by weight of pregelatinized starch or pregelatinized modified starch; about 20% by weight of pectin or pectin derivatives; about 40% by weight of polyisobutylene; and about 20% by weight of cellulose or cellulose derivatives.

[0042] The medical adhesive may contain: about 35% by weight of pregelatinized starch or pregelatinized modified starch; about 20% by weight of pectin or pectin derivatives; about 40% by weight of polyisobutylene; and about 20% by weight of cellulose or cellulose derivatives.

[0043] The medical adhesive may contain: 10 to 20% by weight of pregelatinized starch or pregelatinized modified starch; 10 to 20% by weight of pectin or pectin derivatives; 5 to 20% by weight of polyisobutylene; and 10 to 20% by weight of cellulose or cellulose derivatives.

[0044] In some embodiments, at least 50% of the front surface of the stoma skin barrier device contains medical adhesive. In some embodiments, at least 60%, 70%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or at least 99% of the front surface of the stoma skin barrier device contains medical adhesive. In some embodiments, 50% to 99% of the front surface of the stoma skin barrier device contains medical adhesive. In one embodiment, 55% to 99%, 65% to 99%, 70% to 99%, 70% to 95%, 70% to 90%, or 80% to 90% of the front surface of the stoma skin barrier device contains medical adhesive.

[0045] Medical adhesives can be in the form of layers. The thickness of the adhesive layer can be from 0.05 mm to 2 mm. The thickness of the adhesive layer can be from 0.4 mm to 2 mm. The thickness of the adhesive layer can be from 0.5 mm to 2 mm or from 0.6 mm to 2 mm. In some embodiments, the thickness of the adhesive layer can be from 0.05 mm to 0.4 mm. The thickness of the adhesive layer can be from 0.1 mm to 0.4 mm, 0.05 mm to 0.35 mm, or 0.05 mm to 0.3 mm.

[0046] In some embodiments, the stoma skin barrier device includes a solution-cast hydrocolloid tape ring. The stoma skin barrier device may include a hydrocolloid tape ring containing an adhesive layer with a thickness of 0.01 mm to 0.4 mm, 0.05 mm to 0.35 mm, or 0.05 mm to 0.3 mm. The stoma skin barrier device may include a solution-cast hydrocolloid tape ring containing an adhesive layer with a thickness of 0.01 mm to 0.4 mm, 0.05 mm to 0.35 mm, or 0.05 mm to 0.3 mm.

[0047] In some embodiments, the medical adhesive is a gel. In other embodiments, the medical adhesive is a powder. In some embodiments, the medical adhesive is a powder, and the medical adhesive may contain no more than 1% by weight of polyisobutylene. In some embodiments, the medical adhesive is a powder, and the medical adhesive may contain no more than 0.5% by weight, 0.4% by weight, 0.3% by weight, 0.2% by weight, or no more than 0.1% by weight of polyisobutylene.

[0048] The front surface of the stoma skin barrier device may include a second medical adhesive. This second medical adhesive may be an acrylic adhesive. The second medical adhesive may be disposed towards at least one side of the stoma skin barrier device. The second medical adhesive may be disposed towards at least one outer side of the stoma skin barrier device. The second medical adhesive may cover no more than 40% of the front surface of the stoma skin barrier device. The second medical adhesive may cover no more than 35%, 30%, 25%, 20%, 15%, or no more than 10% of the front surface of the stoma skin barrier device.

[0049] Stoma skin barrier devices may include polymers or polymer matrices. Stoma skin barrier devices may include elastomers. Stoma skin barrier devices may include thermoelastic polymers.

[0050] The opening is sculptable to fit the size of the stoma. The stoma skin barrier device is sculptable to fit the size of the stoma. The stoma skin barrier device is sculptable to cover uneven skin around or beside the stoma.

[0051] The stoma skin barrier device can be attached to the ostomy bag. The stoma skin barrier device can be detachably attached to the ostomy bag.

[0052] In other embodiments, the stoma skin barrier device may not be connected to the ostomy bag, but rather positioned between the ostomy bag and the patient's skin during use to protect the peristaltic skin.

[0053] The stoma skin barrier device may include a plate or sheet for attaching an ostomy bag or stoma pouch. The stoma skin barrier device may also include a connector for attaching the ostomy bag or stoma pouch.

[0054] In a preferred embodiment, an ostomy skin barrier device is provided, comprising: a front and a back, wherein at least a portion of the front comprises a medical adhesive comprising pregelatinized starch or pregelatinized modified starch; and an opening on the skin barrier device for at least partially accommodating the ostomy during use, wherein the pregelatinized starch or pregelatinized modified starch comprises no more than 5% by weight of amylose.

[0055] In a preferred embodiment, an ostomy skin barrier device is provided, comprising: a front and a back, wherein at least a portion of the front comprises a medical adhesive, wherein the medical adhesive comprises pregelatinized starch or pregelatinized modified starch; and an opening on the skin barrier device for at least partially accommodating the ostomy in use, wherein the pregelatinized starch or pregelatinized modified starch comprises at least 95% by weight of amylopectin.

[0056] In a preferred embodiment, an ostomy skin barrier device is provided, comprising: a front and a back, wherein at least a portion of the front comprises a medical adhesive, wherein the medical adhesive comprises pregelatinized starch or pregelatinized modified starch; and an opening on the skin barrier device for at least partially accommodating the ostomy in use, wherein the pregelatinized starch or pregelatinized modified starch is pregelatinized distarch.

[0057] In a preferred embodiment, an ostomy skin barrier device is provided, comprising: a front and a back, wherein at least a portion of the front comprises a medical adhesive, wherein the medical adhesive comprises pregelatinized starch or pregelatinized modified starch; and an opening on the skin barrier device for at least partially accommodating the ostomy in use, wherein the pregelatinized starch or pregelatinized modified starch is pregelatinized distarch adipate.

[0058] In a preferred embodiment, an ostomy skin barrier device is provided, comprising: an ostomy skin barrier device including: a front and a back, wherein at least a portion of the front comprises a medical adhesive, wherein the medical adhesive comprises pregelatinized starch or pregelatinized modified starch; and an opening on the skin barrier device for at least partially accommodating the ostomy in use, wherein the pregelatinized starch or pregelatinized modified starch is pregelatinized distarch adipate or pregelatinized distarch phosphate.

[0059] In a preferred embodiment, an ostomy skin barrier device is provided, comprising: a front and a back, wherein at least a portion of the front comprises a medical adhesive, wherein the medical adhesive comprises pregelatinized starch or pregelatinized modified starch; and an opening on the skin barrier device for at least partially accommodating an ostomy in use, wherein the pregelatinized starch or pregelatinized modified starch is pregelatinized acetylated distarch adipate or pregelatinized hydroxypropyl distarch phosphate.

[0060] According to a second aspect of the invention, a medical adhesive is provided, comprising at least one starch or modified starch, wherein the starch or modified starch comprises no more than 5% by weight of amylose.

[0061] Starch or modified starch may contain no more than 4% by weight, 3% by weight, 2% by weight, 1% by weight, 0.8% by weight, 0.6% by weight, 0.5% by weight, 0.4% by weight, 0.3% by weight, 0.2% by weight, or no more than 0.1% by weight of amylose.

[0062] Any embodiment of the medical adhesive for the stoma skin barrier device of the first aspect of the present invention is applicable to the second aspect of the present invention, except that the starch or modified starch of the second aspect of the present invention may be pregelatinized or not pregelatinized.

[0063] In a preferred embodiment, a medical adhesive is provided comprising at least one starch or modified starch, wherein the starch or modified starch comprises no more than 5% by weight of amylose, and wherein the starch or modified starch is pregelatinized distarch.

[0064] In a preferred embodiment, a medical adhesive is provided comprising at least one starch or modified starch, wherein the starch or modified starch comprises no more than 5% by weight of amylose, and wherein the starch or modified starch is pregelatinized distarch adipate or pregelatinized distarch phosphate.

[0065] In a preferred embodiment, a medical adhesive is provided comprising at least one starch or modified starch, wherein the starch or modified starch comprises no more than 5% by weight of amylose, and wherein the starch or modified starch is pregelatinized acetylated distarch adipate or pregelatinized hydroxypropyl distarch phosphate.

[0066] According to a third aspect of the invention, a medical adhesive is provided, comprising at least one starch or modified starch, wherein the starch or modified starch is pregelatinized potato starch.

[0067] Any embodiment of the medical adhesive for the stoma skin barrier device described in the first aspect of the present invention is applicable to the third aspect of the present invention, except that the starch or modified starch described in the third aspect of the present invention comprises pregelatinized potato starch.

[0068] According to a fourth aspect of the invention, a medical adhesive is provided, comprising at least one starch or modified starch, wherein the starch or modified starch comprises at least 95% by weight amylopectin.

[0069] The starch or modified starch may contain at least 96%, 97%, 98%, or at least 99% amylopectin. The starch or modified starch may contain 100% amylopectin.

[0070] Any embodiment of the medical adhesive for the stoma skin barrier device described in the first aspect of the present invention is applicable to the fourth aspect of the present invention, except that the starch or modified starch described in the fourth aspect of the present invention may or may not be pregelatinized.

[0071] In a preferred embodiment, a medical adhesive is provided comprising at least one starch or modified starch, wherein the starch or modified starch comprises at least 95% by weight of amylopectin, and wherein the starch or modified starch is pregelatinized distarch.

[0072] In a preferred embodiment, a medical adhesive is provided comprising at least one starch or modified starch, wherein the starch or modified starch comprises at least 95% by weight of amylopectin, and wherein the starch or modified starch is pregelatinized distarch adipate or pregelatinized distarch phosphate.

[0073] In a preferred embodiment, a medical adhesive is provided comprising at least one starch or modified starch, wherein the starch or modified starch comprises at least 95% by weight of amylopectin, and wherein the starch or modified starch is pregelatinized acetylated distarch adipate or pregelatinized hydroxypropyl distarch phosphate.

[0074] The medical adhesive of the second, third, or fourth aspect of this invention can contact a backing material. The backing material may comprise materials selected from the group consisting of fibrous materials, hydrogels, modified cellulose, alginate, carboxymethyl cellulose, foams, and polymers such as polyurethane (PU), polyvinyl chloride (PVC), silicone rubber, or fluoropolymers, and any combination thereof. This embodiment is advantageous because it allows the adhesive to be used in wound dressings, wherein the wound dressing improves wet integrity, absorbency, peelability, and tackiness during use.

[0075] The medical adhesive of the second, third, or fourth aspect of the present invention can be a gel. The medical adhesive of the second, third, or fourth aspect of the present invention can be a solid. The medical adhesive of the second, third, or fourth aspect of the present invention can be a powder.

[0076] In some embodiments, the medical adhesive of the second, third, or fourth aspect of the present invention may be a powder, and may contain no more than 1% by weight of polyisobutylene. The medical adhesive of the second, third, or fourth aspect of the present invention may be a powder, and may contain no more than 0.5% by weight, 0.4% by weight, 0.3% by weight, 0.2% by weight, or no more than 0.1% by weight of polyisobutylene.

[0077] According to a fifth aspect of the invention, a stoma skin barrier device is provided, comprising: a front side and a back side, wherein at least a portion of the front side comprises a medical adhesive, wherein the medical adhesive is according to a second, third, or fourth aspect of the invention; and an opening on the skin barrier device, the opening being capable of at least partially accommodating the stoma during use.

[0078] Any embodiment of the stoma skin barrier device described in the first aspect of the present invention is applicable to the fifth aspect of the present invention, except that the adhesive is according to the second, third or fourth aspect of the present invention.

[0079] According to a sixth aspect of the present invention, an ostomy bag is provided, which includes the ostomy skin barrier device described in the first or fifth aspect of the present invention. The ostomy skin barrier device can be attached to the ostomy bag or integrally formed with the ostomy bag.

[0080] According to a seventh aspect of the invention, a kit comprising the stoma skin barrier device and stoma bag described in the first or fifth aspect of the invention is provided. The stoma bag and stoma skin barrier device can be packaged in a suitable container, such as a bag or pouch. Invention Details

[0082] To provide a clearer understanding of the present invention, embodiments thereof are described below by way of example and with reference to the accompanying drawings. The drawings are as follows: Figure 1 A first embodiment of the ostomy skin barrier device (1) and ostomy bag (12) of the first aspect of the present invention is shown.

[0083] Figure 2 It shows Figure 1 The first embodiment of the first aspect of the present invention is an ostomy skin barrier device (1) and an ostomy bag (12), wherein the ostomy skin barrier device (1) and the ostomy bag (12) are connected together.

[0084] Figure 3 A graph showing the amount of water (Δm) absorbed by the medical adhesive (6) of the first embodiment of the ostomy bag of the first aspect of the present invention over 360 minutes at 32°C is shown. The medical adhesive (6) comprises adhesive A of the present invention, adhesive B of the present invention, or adhesive X for illumination.

[0085] Figure 4 shows the inner diameter change curve of the medical adhesive (6) after exposure to physiological saline in a first embodiment of the stoma skin barrier device (1) of the first aspect of the present invention, wherein the medical adhesive (6) includes adhesive A of the present invention, adhesive B of the present invention, adhesive X for illumination, or control unmodified waxy corn starch (ungelatinized).

[0086] Figure 5 shows the inner diameter change curve of a medical adhesive (6) in a first embodiment of the stoma skin barrier device (1) of the first aspect of the present invention after exposure to a physiological saline mixture containing 1 g / L amylase and 1 g / L trypsin, wherein the medical adhesive (6) includes adhesive A of the present invention, adhesive B of the present invention, or adhesive X for illumination.

[0087] Figure 6 shows the average peel force curves of adhesive A, adhesive B, or lighting adhesive X of the present invention.

[0088] Figure 7 shows the maximum tack curves of adhesive A, adhesive B, or lighting adhesive X of the present invention.

[0089] Figure 8 shows a second embodiment of the stoma skin barrier device (101) of the first aspect of the present invention.

[0090] Figure 9 shows a cross-sectional view of a second embodiment of the stoma skin barrier device (101) of the first aspect of the present invention shown in Figure 8.

[0091] Figure 1 illustrates a first embodiment of the stoma skin barrier device (1) and ostomy bag (12) of the first aspect of the present invention. The skin barrier device (1) includes a front side (2) and an opposing back side (4), wherein at least a portion or almost all of the front side (2) comprises a medical adhesive (6) (indicated by dashed lines), wherein the medical adhesive (6) comprises pregelatinized modified starch. The stoma skin barrier device (1) includes an opening (8) adapted to at least partially accommodate an ostomy.

[0092] The back side (4) includes a skin barrier device connector (10) surrounding the opening (8), wherein the skin barrier device connector (10) is adapted to connect to a corresponding ostomy bag connector (20) located on the ostomy bag (12).

[0093] The ostomy bag (12) includes a bag (13) comprising a front panel (14) and a rear panel (16). The front panel (14) includes an opening (18) that, in use, can at least partially accommodate the stoma. The opening (18) is surrounded by an ostomy bag connector (20) adapted for connection with a corresponding skin barrier device connector (10).

[0094] In use, as shown in Figure 2, the stoma skin barrier device (1) is connected to the ostomy bag (12). The front (2) of the stoma skin barrier device (1) contacts and adheres to the patient's skin around the stoma via a medical adhesive (6). Therefore, the back (4) of the stoma skin barrier device (1) faces away from the patient's skin. The stoma skin barrier device connector (10) connects to the corresponding ostomy bag connector (20), such that the back (4) of the stoma skin barrier device (1) contacts the front panel (14) of the ostomy bag (12). The patient's stoma passes through the opening (8) of the stoma skin barrier device and the opening (18) of the ostomy bag, allowing the effluent to enter the bag (13). The back panel (16) of the ostomy bag (12) faces away from the patient's body.

[0095] Example medical adhesives

[0096] Example medical adhesive (6) is prepared according to the formulation in Table 1, wherein the modified pregelatinized starch is pregelatinized acetylated distarch adipate (adhesive A of the present invention) or pregelatinized hydroxypropyl distarch phosphate (adhesive B of the present invention). Adhesive A and adhesive B of the present invention are substantially gelatin-free.

[0097] For comparison, control binders containing gelatin (gelatin binder X) or unmodified waxy corn starch were also prepared.

[0098] Table 1

[0099] The pregelatinized acetylated distarch adipate contains at least 95% by weight of amylopectin and no more than 5% by weight of amylose.

[0100] Pregelatinized hydroxypropyl distarch phosphate contains at least 95% by weight amylopectin and no more than 5% by weight amylose.

[0101] Unmodified waxy corn starch is ungelatinized. It contains at least 95% by weight amylopectin and no more than 5% by weight amylose. The unmodified waxy corn starch used is Sigma-Aldrich® product S9679.

[0102] The water absorption, wet integrity, and enzyme resistance of the medical adhesive (6) containing the formulation of the present invention shown in Table 1 were tested and compared with those of the medical adhesive (6) containing the lighting adhesive X. Furthermore, the wet integrity of the medical adhesive (6) was compared with that of a control adhesive containing unpregelatinized unmodified waxy corn starch.

[0103] The wet integrity test aims to examine the ability of the medical adhesive (6) to maintain its physical form upon contact with a liquid (in this case, physiological saline). This wet integrity test was performed according to ISO 12505-2:2016. The enzyme resistance test aims to examine the ability of the medical adhesive (6) to maintain its physical form upon contact with an enzyme. This enzyme resistance test was performed according to a modified ISO 12505-2:2016 method, in which amylase and trypsin, both at a concentration of 1 g / L, were added to physiological saline.

[0104] Figure 3 shows the water absorption (Δm) of adhesives A, B, and X of the present invention at 32 °C for 360 minutes. The data indicate that the performance of adhesives A and B is comparable to that of adhesive X. This demonstrates that replacing gelatin with pre-gelatinized acetylated distarch adipate or pre-gelatinized hydroxypropyl distarch phosphate in the medical adhesive (6) does not negatively affect the water absorption properties of the medical adhesive (6). In use, this results in a gelatin-free adhesive that retains its adhesiveness after exposure to water, thereby extending its service life.

[0105] Figure 4 shows the wet integrity properties of the medical adhesive (6) by showing the change in the diameter (inner diameter change) of the opening (8) of the stoma device (1) after the medical adhesive (6) is exposed to saline at 32 °C, wherein the medical adhesive (6) comprises either the adhesive (A) or the adhesive (B) of the present invention. The data are compared with the illumination adhesive X and the unpregelatinized control unmodified waxy corn starch adhesive. A negative change in inner diameter indicates that the adhesive expands around the stoma (sealing the stoma). A positive change in inner diameter corresponds to erosion, indicating that the adhesive erodes upon exposure to saline. The results show that the wet integrity properties of the adhesives A and B of the present invention are comparable to those of the illumination adhesive X and superior to the unpregelatinized control unmodified waxy corn starch adhesive. The control unmodified waxy corn starch adhesive exhibits significant erosion compared to the other adhesives. While not strictly adhering to theory, it is understandable that the pregelatinization of starch significantly improves the wet integrity properties of the adhesive.

[0106] When in use, the stoma skin barrier device (1) containing medical adhesive (6) can form a seal around the stoma, thereby preventing the patient's skin from being damaged by the outflow.

[0107] Figure 5 shows the change (inner diameter change) of the opening (8) of the stoma device (1) after exposure to a mixture of physiological saline with a total enzyme concentration of 2 g / L and containing 1 g / L trypsin and 1 g / L amylase, wherein the medical adhesive (6) comprises adhesive A, adhesive B of the present invention, or illuminant adhesive X. Trypsin breaks down proteins, and amylase breaks down starch. Illuminant adhesive X is significantly eroded after exposure to the enzymes, while adhesive A and adhesive B of the present invention are not. This indicates that adhesive A and adhesive B of the present invention have higher enzyme resistance, thereby making the medical adhesive more durable, wherein the adhesive is able to maintain a seal around the stoma, thereby preventing damage to the patient's skin from exudate.

[0108] Figure 6 The average peel force of adhesive A, adhesive B, and illumination adhesive X of the present invention is shown. The peel force was measured by the following method. A medical adhesive sample was prepared comprising a polyethylene backing, a medical adhesive layer comprising adhesive A, adhesive B, or illumination adhesive X of the present invention, and silicone release paper. TESA 4590 (monofilament tape, 25 mm wide) was gently pressed onto the polyethylene side of the sample to adhere it. The medical adhesive sample was applied to a substrate using a ChemInstruments Rolldown machine and rolled once at a speed of 60 cm / min. The substrate was stainless steel or Teflon. The medical adhesive sample and the substrate were placed on a slide table, and the substrate was secured with clamps. The force required to peel the medical adhesive sample from the substrate was measured. The peel speed was 200 mm / min or 600 mm / min. Adhesive A, adhesive B, and illumination adhesive X of the present invention were tested under the same conditions, and the comparative data are presented in Figure 6. Data shows that the peel strength of adhesive A, adhesive B, and lighting adhesive X of the present invention is comparable; therefore, replacing gelatin adhesive with medical adhesives containing pre-gelatinized acetylated distarch adipate or pre-gelatinized hydroxypropyl distarch phosphate does not reduce the peel performance of medical adhesives.

[0109] Figure 7 shows the maximum tack force of adhesive A, adhesive B, and the lighting adhesive X of the present invention. The tack force was measured using a tack test probe with a 10 N load sensor. The test speed was 600 mm / min, and the holding time was 1 second. The adhesives of the present invention and the control adhesive were tested under the same conditions, and the comparative data are shown below. Figure 7As shown. Data shows that the adhesive forces of adhesive A, adhesive B, and lighting adhesive X of the present invention are comparable; therefore, replacing gelatin adhesive with medical adhesives containing pregelatinized acetylated distarch adipate or pregelatinized hydroxypropyl distarch phosphate does not reduce the adhesive properties of the medical adhesive.

[0110] In summary, the skin barrier device (1) comprising the medical adhesive (6) of the present invention has advantages because it enables the skin barrier device (1) and the ostomy bag (12) to adhere firmly to the patient, thereby allowing the patient to comfortably perform daily activities. The medical adhesive (6) of the present invention has advantages because it is gelatin-free, and therefore can be used on damaged or cracked skin, reducing the risk of infection, while maintaining high water integrity, considerable water absorption, and considerable peel and adhesive properties.

[0111] In use, the present invention provides a gelatin-free skin barrier device (1) that maintains adhesion to the skin when exposed to water (e.g., sweat), maintains a seal around the patient's stoma, and has higher enzyme resistance. All these characteristics together make the skin barrier device (1) have more durable adhesion, less leakage, and less skin irritation around the stoma, thereby extending the wearing time.

[0112] Figures 8 and 9 illustrate a second embodiment of the stoma skin barrier device (101) of the first aspect of the present invention. The skin barrier device (101) includes a front side (102) and an opposing back side (104), wherein at least a portion or almost all of the front side (102) comprises a medical adhesive (106), indicated by dashed lines, which comprises pregelatinized modified starch. The stoma skin barrier device (101) includes an opening (108) adapted to at least partially accommodate a stoma.

[0113] The medical adhesive (106) is a medical adhesive (6) according to the first embodiment of the stoma skin barrier device (1).

[0114] In use, the front side (102) of the stoma skin barrier device (101) contacts and adheres to the patient's peristolic skin via the medical adhesive (106) of the present invention, allowing the patient's stoma to be at least partially inserted into the opening (108). The stoma skin barrier device (101) can then contact another skin barrier device, adhesive patch, or ostomy bag. The stoma skin barrier device (101) is advantageous because it protects the patient's peristolic skin from abrasions or irritation. The stoma skin barrier device (101) is particularly advantageous if the peristolic skin is uneven, as the good wet integrity of the adhesive (106) ensures a strong seal once the skin barrier device is applied to the skin and maintains the structural integrity of the adhesive even when exposed to water and / or enzymes, thereby reducing leakage or skin irritation.

[0115] A third embodiment of the stoma skin barrier device according to the first aspect of the present invention is provided, wherein the stoma skin barrier device includes: a front side and an opposing back side, wherein at least a portion or almost all of the front side comprises a medical adhesive comprising pregelatinized starch. The stoma skin barrier device includes an opening adapted to at least partially receive an stoma. The back side includes a skin barrier device connector surrounding the opening, wherein the skin barrier device connector is adapted to connect to a corresponding stoma pocket connector located on an ostomy pocket.

[0116] The third embodiment of the stoma skin barrier device is substantially the same as the first embodiment, except that its medical adhesive includes pregelatinized starch instead of pregelatinized modified starch. The pregelatinized starch is pregelatinized potato starch. The medical adhesive comprises: 20% by weight of pregelatinized potato starch; 20% by weight of pectin; 40% by weight of polyisobutylene; and 20% by weight of carboxymethyl cellulose.

[0117] A fourth embodiment of the stoma skin barrier device of the first aspect of the present invention is provided, wherein the stoma skin barrier device includes: a front side and an opposing back side, wherein at least a portion or almost all of the front side comprises a medical adhesive, wherein the medical adhesive comprises pregelatinized starch. The stoma skin barrier device includes an opening adapted to at least partially receive the stoma.

[0118] The fourth embodiment of the stoma skin barrier device is substantially the same as the second embodiment, except that its medical adhesive contains pregelatinized starch instead of pregelatinized modified starch. The pregelatinized starch is pregelatinized potato starch. The medical adhesive comprises: 20% by weight of pregelatinized potato starch; 20% by weight of pectin; 40% by weight of polyisobutylene; and 20% by weight of carboxymethyl cellulose.

[0119] The above embodiments are merely examples. Many modifications can be made without departing from the scope of the invention as defined by the appended claims.

Claims

1. A stoma skin barrier device, comprising: The front and back sides, wherein at least a portion of the front side comprises a medical adhesive, wherein the medical adhesive comprises pregelatinized starch or pregelatinized modified starch; as well as The opening on the skin barrier device is used to at least partially accommodate the stoma during use.

2. The stoma skin barrier device according to claim 1, wherein the pregelatinized starch or pregelatinized modified starch comprises no more than 5% by weight of amylose.

3. The stoma skin barrier device according to claim 1 or 2, wherein the pregelatinized starch or pregelatinized modified starch comprises at least 95% by weight amylopectin.

4. The stoma skin barrier device according to any one of the preceding claims, wherein the pregelatinized starch or pregelatinized modified starch is uncrosslinked.

5. The stoma skin barrier device according to any one of claims 1 to 3, wherein the pregelatinized starch or pregelatinized modified starch is cross-linked.

6. The stoma skin barrier device according to any one of the preceding claims, wherein the amount of said pregelatinized starch or pregelatinized modified starch is 10 to 40% by weight of the total weight of the adhesive.

7. The stoma skin barrier device according to any one of the preceding claims, wherein the pregelatinized starch or pregelatinized modified starch is pregelatinized distarch.

8. The stoma skin barrier device according to any one of the preceding claims, wherein the pregelatinized starch or pregelatinized modified starch is pregelatinized distarch adipate or pregelatinized distarch phosphate.

9. The stoma skin barrier device according to any one of the preceding claims, wherein the pregelatinized starch or pregelatinized modified starch is pregelatinized acetylated distarch adipate or pregelatinized hydroxypropyl distarch phosphate.

10. The stoma skin barrier device according to any one of the preceding claims, wherein the medical adhesive comprises pectin.

11. The stoma skin barrier device of claim 10, wherein the amount of pectin is 10 to 30% by weight of the total weight of the adhesive.

12. The ostomy skin barrier device according to any one of the preceding claims, wherein the adhesive comprises polyisobutylene.

13. The stoma skin barrier device according to claim 12, wherein the amount of polyisobutylene is 5 to 50% by weight of the total weight of the adhesive.

14. The stoma skin barrier device according to any one of the preceding claims, wherein the adhesive composition comprises cellulose or a cellulose derivative.

15. The stoma skin barrier device according to claim 14, wherein the cellulose derivative is carboxymethyl cellulose.

16. The stoma skin barrier device according to claim 14 or 15, wherein the amount of the cellulose derivative is 10 to 30% by weight of the total weight of the adhesive.

17. The stoma skin barrier device according to any one of the preceding claims, wherein the medical adhesive comprises: 10 to 40% by weight of pregelatinized starch or pregelatinized modified starch; 10 to 30% by weight of pectin; 5 to 50% by weight of polyisobutylene; and 10 to 30% by weight of cellulose or cellulose derivatives.

18. The stoma skin barrier device according to any one of the preceding claims, wherein the thickness of the adhesive layer is from 0.05 mm to 2 mm.

19. A medical adhesive comprising at least one starch or modified starch, wherein the starch or modified starch comprises no more than 5% by weight of amylose.

20. A medical adhesive comprising at least one starch or modified starch, wherein the starch or modified starch comprises at least 95% by weight amylopectin.

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